Present: Professor Martin Gore, Professor Richard Ashcroft, Professor Andrew Baker, Dr Kathleen Bamford, Mrs Debbie Beirne, Professor Hilary Calvert, Professor Mary Collins, Professor Terry Hamblin, Dr Peter Harris, Professor Nick Lemoine, Dr Adrian Lepper, Dr Stephen Minger, Bishop Dr Lee Rayfield, Mrs Fiona Sandford, Dr Michael Waterhouse. Co-opted Dr Angela Thomas
Observers: Dr Paul Logan (HSE), Dr Riaz Zuhire (MHRA)
Secretariat: Dr Monika Preuss, Miss Joanna Edwards, Mr Daniel Gooch and Mrs Halina Pounds.
Apologies: Mrs Claire Foster, Professor David Harrison, Mr Michael Harrison

Item 1: Welcome

Professor Martin Gore, the Chair, opened the meeting by welcoming members to the 64th GTAC meeting. He informed the Committee that Dr Angela Thomas had been co-opted onto the Committee for the afternoon session as an expert in paediatric haematology.

Item 2: Minutes of the 66th meeting of GTAC

The minutes were agreed as an accurate and true record of the 66th meeting.

Item 3: Matters Arising

A number of letters had been sent out, and received, concerning correspondence arising from the last meeting. There were no comments.

Item 4: Chairman's Actions

Six letters had been sent out under Chairman's Actions since the last meeting, none of which gave rise to any discussion.

Item 5: New Protocol GTAC 150: Assessment of protection against malaria by sporozoite challenge of healthy adults vaccinated with AdCh63 ME-TRAP and MVA ME-TRAP

This was the first time the Committee has reviewed this type of protocol. It is a malaria challenge study where healthy volunteers will be exposed to malaria.

There was a short discussion on this trial before conditional approval was given.

Item 6: New Protocol GTAC 149: A multicenter double blind placebo controlled randomized study of TroVax vs placebo in the first line treatment of patients with metastatic colorectal cancer receiving standard of care

Colorectal or bowel cancer is cancer of the colon or rectum. It is the third most common form of cancer and the second leading cause of cancer related death in the West, causing some 655,000 deaths per year.

This study uses TroVax which is well known to the Committee from several previous applications only one of which was in respect of colorectal cancer but in a slightly different cohort of patients.

The Committee briefly discussed this protocol before giving approval.

Item 7: New Protocol GTAC 148: Phase I randomized double blind placebo controlled trial to evaluate the safety and immunogenicity of TBC-M4, an env, gag, tat-rev and nef-RT MVA HIV vaccine and a prime boost regimen with ADVAX, an env, gag, nef-tat and pol DNA HIV vaccine and TBC-M4

This application was for a prime boost regime designed to evaluate the immunogenicitiy of TBC-M4 when combined with ADVAX. There are two arms to this trial, one is using ADVAX as the prime and TBC-M4 as the boost and the other using both the prime and the boost as TBC-M4.

The Committee discussed this protocol before giving approval.

Item 8: IRAS Application Form and Question Specific Guidence

The Committee was advised that IRAS (Integrated Research Application System) was launched on 29 January 2008. Under IRAS, 7 bodies have merged their information requirements (ARSAC, GTAC, MHRA Devices, NHS R&D, NRES, PIAG and Ministry of Justice). Applicants to GTAC will be encouraged to use this application form as it means that researchers need to enter information required by more than one body only once which is hoped will make the application process easier and less bureaucratic.

Item 9: Transfer of Applications and the Outcome of 28 January Workshop

On 28 January a workshop with GTAC members and gene therapy stakeholders had been held in order to discuss the implications of the anticipated amendments to the Clinical Trials Regulations in relation to the delegation of "low risk" clinical trials to NHS RECs. This workshop was chaired by Prof David Harrison.

Item 10: Consultation: Annex 2 of the European Commission GMP Guide - Manufacture of Biological Medicinal Products for Human Use

This Consultation, issued by the European Commission, proposes amendments to the Good Manufacturing Practice for biologicals used as medicinal products for human use.

A short discussion on the implications was held which the Secretariat noted in order to draft a response.

Item 11: New Protocol GTAC 146: Phase I/II clinical trial of haematopoietic stem cell gene therapy for Wiskott Aldrich Syndrome

Wiskott Aldrich Syndrome (WAS) is a primary immunodeficiency disease similar to X-SCID however in WAS there is some residual T cell function. There are many different mutations that cause WAS, some run in families and can help in confirmation of the disease, others are spontaneous and are unique to the individual. The different mutations vary in intensity and symptoms.

The Committee discussed this trial in some detail before giving the group conditional approval.

Item 12: New Protocol GTAC 147: Immunotherapy with CD19? chimeric receptor gene modified EBV-specific CTLs after stem cell transplant in children with high risk acute lymphoblastic leukaemia

The study was for Acute Lymphoblastic Leukaemia (ALL), a very common form of childhood cancer.

The Committee gave approval to this study.

Item 13: Presentation on ATMP Regulations

The Committee received a short presentation on ATMP regulations.

Item 14: X-SCID Update

The Committee reviewed a selection of articles, press cuttings and correspondence available since the X-SCID case was made public just before Christmas and was given the latest information on the progress made by the participant to date.

Item 15: SUSARs

The Committee noted the eight new SUSARs reported since the previous meeting.

Item 16: Any Other Business

• GTAC 108 - Breach of GCP

A notification of a breach of GCP was tabled at the meeting for discussion. The breach occurred last November when a participant received a higher dose of the research drug than was specified in the protocol. The trial is now closed for recruitment and the MHRA has also been informed.

Committee members noted the breach

• GTAC 092 - End of Study Notice

The Committee reviewed the letter received informing them of the fact that this study had been abandoned due to an unfortunate sequence of events. It was useful to note how events in other parts of the world impacted on research being held in the UK.

Item 17: Press Cuttings

NEXT MEETING: Wednesday, 30 April 2008

GTAC Secretariat
May 2008

Top

copyright: © | last updated 27 March 2007